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IFU for Sterling Silver Surgical devices

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phoenix2368

Starting to get Involved
#1
#1
I work in Surgical Instruments Company, Some of our Instruments are of Sterling Silver. Sterling silver is used to make them ductile and malleable, just like Sims Sounds or Bowman Lacrimal Probes. The problem is that they get tarnished after a while. I checked all other major companies IFU's for sterling silver , but every ones IFU's say follow the manufacturers instructions. I contacted our German manufacturers regarding the shelf life of surface finish of Sterling Silver but they said that no such study been performed in Germany and when they see that thier items are getting tarnished in the shelves they just re polish them. And as such they dont have any IFU specifically for sterling silver items.
I googled any IFU for sterling silver devices used in Medical/Surgical industry but with no avail.
Can someone help me regarding some research or an IFU on Sterling Silver instruments.:cool::cool:

[FONT=&quot]I asked 2 of our vendors regarding shelf life of sterling silver surface finish , I found Some kind of Surface Finish shelf life sheet (Attached herewith) which said that it is about 6 months and after 6 months it will start getting tarnished. But another of my question is, suppose the shelf life of the finish is 6 months and we have that item in our stock for 5½ months and than we supply to our customer and within 2 weeks the item start getting tarnished so what warranty we can promise to our customer.[/FONT]
[FONT=&quot]Confusing….. Right[/FONT]
 

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QMS for Medical Device Companies
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hello and welcome to the Cove :bigwave:

IMO anything medical with a shelf life of 6 months is very problematic to manage. The options I see for you:

1. Someone needs to objectively establish that the tarnishing doesn't affect safety and efficacy, and is only a cosmetic effect. This should then be communicated to customers and users, e.g. in the IFU.

2. Failing option 1, someone needs to establish a method for monitoring the finish and repolishing as required, without damaging the device's safety and efficacy. This MUST then be communicated to customers and users in the IFU.

3. Failing options 1&2, you need to establish a very efficient stock management system and clearly inform your customers upfront of the issue and the shelf life you can guarantee.

Cheers,
Ronen.
 
P

phoenix2368

Starting to get Involved
#4
#4
Since none of the Major Medical Device companies have any specific IFU on sterling Silver Instruments and were issuing a general IFU for them and it was a recurring problem for hospitals, retailers and manufacturers that how to handle the Tarnishing problem.

I made an IFU , and posting it if any one else is facing same questions and same issues.

You are most welcome to point out any deficiencies in this document.

Correction and prevention is our job.
 

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